In cancer patients, social support provided by partners, family and/or friends plays a key role in coping with the disease and reducing treatment-related distress. However, research indicates that some of the needs of patients, such as coping with the disease, reducing isolation or managing guilt, often go unmet. With the aim of trying to meet these types of needs of people with cancer, the present research will evaluate the effectiveness of a peer support program in cancer patients, based on the support provided or exchanged by people who have faced similar challenges or problems. The intervention will consist of 8 face-to-face sessions of social peer support, involving a cancer patient and a volunteer who is in a stable phase and who has undergone the same diagnosis and medical treatment. To evaluate the effectiveness of the social support program, the immediate and long-term effect of participation in the program on both psychological (anxious-depressive symptoms, quality of life, perception of the disease, coping strategies, perception of social support,...) and biological (endocrine and immune system) variables will be analyzed.
The general aim of the present research will be to evaluate the effectiveness of a peer social support intervention in cancer patients at the Onkologikoa Foundation of Guipuzcoa. Specifically, the immediate and long-term effect that such intervention will have on symptoms of psychological distress, quality of life, coping strategy, perception of social support, perception of the disease and emotional regulation will be evaluated. As a secondary aim of this study, we intend to evaluate the immediate and long-term effect of the peer social support intervention on the immune system (through the determination of the levels of cytokines IL-1β, IL-2, IL-6, IL-8, IL-10, IFN-γ and TNF-α), on the monoaminergic system (through the determination of plasma levels of serotonin, tyrosine, phenylalanine, tryptophan, quinurenine, quinurenic acid and 3-HK), on the HPA axis (through the measurement of the diurnal cycle of cortisol), and on sex hormones (through the measurement of estradiol and testosterone levels), systems that have been related both to the development of anxious-depressive symptoms and to the development, progression and recurrence of cancer. In addition, it will be studied at what time the application of the program is most effective, being applied in newly diagnosed patients (experimental group 1) and in patients who have just finished medical treatment (experimental group 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
120
The intervention will consist of 8 face-to-face peer social support sessions conducted by volunteers diagnosed with breast cancer who have finished their medical treatment (chemotherapy, radiotherapy, surgery) or who have been in a stable phase for at least two years and who are motivated to participate in this type of intervention.
Onkologikoa
San Sebastián, Guipuzcoa, Spain
RECRUITINGPsychological distress scale HADS
Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.
Time frame: baseline
Social support perception scale MOS-SSS
The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception
Time frame: baseline
Coping scale COPE28
The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping
Time frame: baseline
Resilience scale
The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience
Time frame: baseline
Quality of life scale SF-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.
Time frame: baseline
emotional inteligence scale TMMS
The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence
Time frame: baseline
illness perception scale
The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception
Time frame: baseline
Cortisol levels
Cortisol is a hormone that is mainly released at times of stress
Time frame: baseline
Cytokine levels of IL-6 and TNF-a
Cytokines are a broad and loose category of small proteins (\~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms
Time frame: baseline
Estradiol levels
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
Time frame: baseline
Monoamines levels
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Time frame: baseline
Psychological distress scale HADS
Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression. Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing.
Time frame: four months after
Social support perception scale MOS-SSS
The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception
Time frame: four months after
Coping scale COPE28
The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping
Time frame: four months after
Resilience scale
The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience
Time frame: four months after
Quality of life scale SF-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.
Time frame: four months after
emotional inteligence scale TMMS
The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence
Time frame: four months after
illness perception scale
The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception
Time frame: four months after
Cortisol levels
Cortisol is a hormone that is mainly released at times of stress
Time frame: four months after
Cytokine levels of IL-6 and TNF-a
Cytokines are a broad and loose category of small proteins (\~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms
Time frame: four months after
Estradiol levels
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
Time frame: four months after
Monoamines levels
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Time frame: four months after
Psychological distress scale HADS
Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.
Time frame: through treatment completion, an average of eight months
Social support perception scale MOS-SSS
The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception
Time frame: through treatment completion, an average of eight months
Coping scale COPE28
The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping
Time frame: through treatment completion, an average of eight months
Resilience scale
The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience
Time frame: through treatment completion, an average of eight months
Quality of life scale SF-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.
Time frame: through treatment completion, an average of eight months
emotional inteligence scale TMMS
The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence
Time frame: through treatment completion, an average of eight months
illness perception scale
The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception
Time frame: through treatment completion, an average of eight months
Cortisol levels
Cortisol is a hormone that is mainly released at times of stress
Time frame: through treatment completion, an average of eight months
Cytokine levels of IL-6 and TNF-a
Cytokines are a broad and loose category of small proteins (\~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms
Time frame: through treatment completion, an average of eight months
Estradiol levels
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
Time frame: through treatment completion, an average of eight months
Monoamines levels
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Time frame: through treatment completion, an average of eight months
Psychological distress scale HADS
Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.
Time frame: four months after treatment completion
Social support perception scale MOS-SSS
The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception
Time frame: four months after treatment completion
Coping scale COPE28
The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping
Time frame: four months after treatment completion
Resilience scale
The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience
Time frame: four months after treatment completion
Quality of life scale SF-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.
Time frame: four months after treatment completion
emotional inteligence scale TMMS
The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence
Time frame: four months after treatment completion
illness perception scale
The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception
Time frame: four months after treatment completion
Cortisol levels
Cortisol is a hormone that is mainly released at times of stress
Time frame: four months after treatment completion
Cytokine levels of IL-6 and TNF-a
Cytokines are a broad and loose category of small proteins (\~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms
Time frame: four months after treatment completion
Estradiol levels
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
Time frame: fofour months after treatment completion
Monoamines levels
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Time frame: four months after treatment completion
Psychological distress scale HADS
Hospital Anxiety and Depression Scale ( HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The total score is out of 42, (21 per anxiety and 21 per depression). Higher scores indicate greater levels of anxiety or depression.
Time frame: one year after treatment completion
Social support perception scale MOS-SSS
The Social Support Scale (MOS-SSS) aims to assess the extent to which the person has the support of others to face stressful situations. 19 items with answer categories that range on a 7-point rating scale. Higher scores indicate greater levels of social support perception
Time frame: one year after treatment completion
Coping scale COPE28
The COPE inventory was created by Carver (1989). It is a multi-dimensional inventory developed to asses the different coping strategies people use in response to stress. Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26. Range: 2-8. Higher scores indicate greater levels of coping
Time frame: one year after treatment completion
Resilience scale
The Resilience Scale (RS) was developed to evaluate the levels of resilience in the general population. The items are rated on a 7-point scale ranging 1 (strongly disagree) to 7 (strongly agree), with a score ranging 14 to 98. Higher scores indicate greater levels of resilience
Time frame: one year after treatment completion
Quality of life scale SF-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of physical and mental component scores (PCS/MCS), ranging from 0 to 100. Higher scores indicate greater quality of life.
Time frame: one year after treatment completion
emotional inteligence scale TMMS
The Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995) is a well-established measure of perceived emotional intelligence, an aspect of emotional intelligence that includes people's beliefs and attitudes about their own emotional experience. The TMMS-24 contains three key dimensions of emotional intelligence with 8 items each: Emotional Attention, Emotional Clarity and Emotional Repair. The score ranges from 7 to 56. Higher values indicate higher emotional intelligence
Time frame: one year after treatment completion
illness perception scale
The Illness Perception Questionnaire (IPQ) is a widely used multifactorial pencil-and-paper questionnaire which assesses the five cognitive and emotional illness representations and comprehensibility. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Higher scores indicate greater levels of illness perception
Time frame: one year after treatment completion
Cortisol levels
Cortisol is a hormone that is mainly released at times of stress
Time frame: one year after treatment completion
Cytokine levels of IL-6 and TNF-a
Cytokines are a broad and loose category of small proteins (\~5-20 kDa) important in cell signaling. Cytokines have been related with anxiety and depression symptoms
Time frame: one year after treatment completion
Estradiol levels
Sexual hormones as estradiol play an important role in mammary carcino- genesis, being able to induce carcinogenic initiation, promotion and progression
Time frame: one year after treatment completion
Monoamines levels
Monoamines refer to the particular neurotransmitters dopamine, noradrenaline and serotonin. These neurotransmitters are involved in different psychopathologies.
Time frame: one year after treatment completion
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